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BLOG: Shire is the ‘hot dot’ at ASCRS
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Man, talk about making an entrance! The buzz at ASCRS was all about the newest entrant into the eye care space, Shire. If you are like most folks in ophthalmology, you have no idea that Shire is an Irish pharmaceutical company headquartered just outside of Boston and known for making highly specialized drugs to treat rare diseases. Heck, a number of very senior execs in our most established eye care companies were seen shaking their heads and mumbling, “Who ARE those guys?!” I’ll bet the Shire execs found it a bit weird to be an unknown because it is a really huge company not accustomed to flying under the radar.
On the heels of the meeting came the news that Shire had been granted an expedited review of its new dry eye drug, lifitegrast. Now we know why it was in San Diego. The FDA announced that it will rule on the lifitegrast NDA on Oct. 25. As you are probably aware, this is typically done only for those new drugs that are deemed particularly promising. For those of you keeping score at home, Oct. 25 is right before AAO. Talk about a big Vegas opening act!
What makes this a big deal is that lifitegrast is the first truly new official entry on the pharmaceutical side of the dry eye world since Restasis (cyclosporine ophthalmic emulsion 0.05%, Allergan). While most of us would consider AzaSite (azithromycin ophthalmic solution, Akorn) to be a dry eye drug, it continues to have an on-label approval for only bacterial conjunctivitis; as you know, this makes it a maddening proposition to prescribe. The NDA for lifitegrast, on the other hand, includes a requested indication specifically for the treatment of dry eye.
At first blush, this would seem to put lifitegrast (and Shire) in direct competition with Restasis (and Allergan). I think it’s very premature to entertain this line of thought. We should remember that there are at least 30 million Americans with dry eye (as many as 60 million by my count), only about a million of whom are now being treated. In my opinion, we should be concentrating on getting more folks treated. Full stop. Both drugs can grow quite handsomely in this setting if lifitegrast is approved. For now I will continue to stand by my long-held position: You can’t be really good at treating dry eye unless you know how to use Restasis and prescribe it in appropriate settings.
Could be quite a show in Vegas come November.
Disclosure: White is a consultant for Bausch + Lomb, Allergan, Nicox, Shire and Eyemaginations. He is on the speakers board for Bausch + Lomb and Allergan.